Researcher Responsibility

SPONSORSHIP OF APPLICATIONS

Some research involving human subjects must be sponsored by a responsible investigator. Investigators whose appointments carry the approved rank codes do not require sponsorship (primarily, tenured or tenure-track faculty; tenure or tenure-track librarians; lecturers; and full-time salaried clinical or research rank appointees). See the end of this section for a list of rank titles and their codes. All other investigators, including students, staff, research associates, postdoctoral fellows, non-salaried clinical rank appointees, non-tenure track faculty and librarians, and part-time or visiting appointees must be sponsored by one or more full-time IUSB faculty, librarian, senior lecturer, salaried clinical rank, or research rank appointee whose primary appointment carries one of the below-listed rank codes.

Sponsorship is more than simply a signature, and carries two responsibilities: (1) supervision of the research, and (2) assistance in preparing the application for Institutional Review Board (IRB) approval. While the IRB is able to offer assistance in how to complete the applications, it cannot take the place of the sponsor.

When a student is working on a project that already has human subjects approval, and that student will use some of that data to fulfill a course or degree requirement, such as honor's thesis, first-year project, or master's degree, the original principal investigator must submit an amendment to the IRB requesting the student to be added as a co-investigator on his/her project for the stated purpose. Any student working in the same capacity but who wishes to use the data for his/her dissertation must submit a separate application to the IRB describing the project and the data to be used. In all other situations student-initiated research must be submitted as an independent project, NOT as an amendment to an already approved protocol. All student projects must be sponsored by one or more full-time IUSB faculty, librarian, senior lecturer, salaried clinical rank, or research rank appointee. If the sponsor's appointment is at another campus, applications are now to be reviewed according to where the research is to take place, as well as according to where the student or sponsor is located. If a project will take place solely on another IU campus, the project must be reviewed on that campus. Please see the new policy for more details.

Persons with the following ranks are approved to submit, or sponsor, an application to use human subjects in a research project.

FOLLOW-UP

The IRB suggests that researchers be aware that materials can get lost in the mail. If an investigator has submitted an application but hasn't heard from the IRB within two weeks, the investigator should contact the IRB. If the investigator has provided an e-mail address, the IRB will use that means to convey any questions to the investigator. If no e-mail address is provided, a written memo will be sent to the address the investigator provides. However, communication from a full review will, in most cases, be by written letter sent via campus or U.S. mail, depending upon the address provided by the investigator. For applications with a sponsor, the sponsor will be copied on all communication with the investigator.

The IRB allows approximately one month from the time it sends questions to the investigator before it will recontact the investigator as follow-up. If the Committee does not receive a response from the investigator by the end of 2 months, the application will be considered not approved/withdrawn.

FILE MAINTENANCE

It is important for investigators to KEEP A COPY of every document related to the research project which is submitted to the IRB. For audit purposes, these documents, and signed consent forms, must be kept for at least three (3) years after terminating the study. The IRB will NOT be responsible for duplicating any information submitted to the IRB.

Research files involving investigational drugs used in the United States must be maintained for two (2) years after the FDA's approval or denial of a New Drug Application (NDA) or two (2) years after a sponsor withdraws an NDA submission. Research files involving investigational drugs used in global trials must be maintained for at least fifteen (15) years after the date of the termination of the study.